Quality Assurance In-charge

3 days ago

Thane, India Dr. Palep's Medical Research Foundation Pvt. Ltd. Full time

**Key Responsibilities**:1. **Documentation & Compliance**
- Ensure **GMP (Good Manufacturing Practices)** and **AYUSH guidelines** are strictly followed.
- Maintain and review **Standard Operating Procedures (SOPs)**, Batch Manufacturing Records (BMR), and Batch Packing Records (BPR).
- Manage change control, deviation reports, CAPA (Corrective and Preventive Actions), and risk assessments.
- Maintain updated **regulatory documents** as per FDA, AYUSH, and ISO requirements.

2. **Batch Release & Review**
- Ensure **line clearance** before manufacturing and packaging activities.
- Review **batch records** and ensure compliance before batch release.
- Verify in-process quality control (IPQC) and coordinate with production for real-time corrections.

3. **Audits & Inspections**
- Prepare and face **internal, external, and regulatory audits** (FDA/AYUSH/ISO).
- Ensure timely closure of audit observations and prepare audit reports.

4. **Training & Development**
- Conduct **GMP training programs** for production, QC, and warehouse staff.
- Ensure all employees are updated with current **quality standards and practices**.

5. **Supplier & Material Quality Management**
- Review and approve **vendor qualifications**, raw materials, and packaging materials.
- Maintain **raw material specifications** and conduct periodic vendor audits.

6. **Quality Risk Management**
- Conduct **root cause analysis (RCA)** for deviations and complaints.
- Lead CAPA implementation and ensure **product safety and efficacy**.

7. **Product Quality & Market Complaints**
- Monitor **product stability** and conduct trend analysis.
- Investigate and report **market complaints** and product recalls if required.

8. **Coordination with Other Departments**
- Coordinate closely with Production, QC, R&D, and Warehouse teams.
- Support New Product Development (NPD) by ensuring documentation and quality compliance.

**Desirable Skills & Knowledge**:

- Knowledge of **Ayurvedic formulation standards**.
- Familiarity with **Schedule T**, AYUSH guidelines, and GMP norms.
- Attention to detail, leadership, and strong communication skills.
- Proficient in MS Office and QMS software.

Pay: ₹30,000.00 - ₹40,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

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